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Good Laboratory Practice (GLP) – 21 CFR Part 58 refers to the set of regulatory standards for laboratories established by the U.S. Food and Drug Administration (FDA) to ensure the quality, reliability, and integrity of nonclinical laboratory studies. These standards apply to research conducted to support applications for FDA approval of drugs, biologics, medical devices, food additives, and other regulated products. GLP principles are designed to guarantee that nonclinical safety data are scientifically valid and can be confidently used to evaluate product safety before human clinical trials or market authorization.
Under 21 CFR Part 58, laboratories must operate within a structured quality system that includes trained personnel, validated equipment, written procedures, accurate documentation, and independent quality assurance oversight. Every aspect of study design, data collection, and reporting must follow established protocols to maintain transparency and traceability.
By requiring consistency and accountability throughout the research process, GLP protects against data manipulation and ensures that results accurately reflect study outcomes. Compliance with these standards provides scientific credibility and regulatory confidence, forming the foundation for the safe and ethical advancement of products through the FDA approval process.
The framework of GLP under 21 CFR Part 58 forms a central part of the broader network of laboratory quality systems that support product safety and scientific integrity in the life sciences industry. It works alongside other regulatory structures, including ISO 13485, which governs medical device quality management, and the FDA Quality Management System Regulation (QMSR), which sets standards for medical device quality and design. Together, these systems establish the compliance requirements that ensure every phase of research and production meets consistent, verifiable standards of quality and reliability.
The guiding philosophy behind GLP and its related frameworks is grounded in transparency, reproducibility, and accountability. These principles arose from the need to prevent unreliable or falsified data and to ensure that nonclinical safety studies submitted to the FDA are scientifically sound. GLP provides structured methods for study planning, documentation, and data handling so that results can be trusted and reproduced. Enforcing discipline within laboratory quality systems ensures all studies supporting product approvals are traceable and credible.
The scope and jurisdiction of these frameworks extend across laboratories, manufacturers, and research institutions regulated by the FDA. While GLP focuses on nonclinical laboratory studies, the QMSR applies to product manufacturing, and ISO 13485 serves as a global benchmark for quality management systems. Together, they form a cohesive regulatory architecture that spans from early-stage testing to postmarket oversight of medical devices.
Historically, these compliance requirements evolved after the 1970s, when concerns over data integrity led the FDA to establish GLP in 1978. This milestone marked the beginning of formalized laboratory oversight. Since then, the principles of GLP have become aligned with global quality standards to ensure consistency, integrity, and trust in the scientific evidence supporting public health decisions.
The requirements of Good Laboratory Practice (GLP) under 21 CFR Part 58 define how laboratories must operate to ensure the integrity, consistency, and reliability of nonclinical safety studies. These specific rules and standards govern every aspect of laboratory activity, from personnel responsibilities and facility conditions to data recording and final reporting. The goal is to maintain a controlled environment in which every process can be verified and every result can be traced back to its source.
GLP compliance depends on meeting concrete criteria and technical specifications that guarantee study integrity. Laboratories must have clearly defined roles, qualified staff, and appropriate facilities that prevent cross-contamination and mix-ups. Equipment must be properly maintained, calibrated, and validated for accuracy. Each study must be conducted according to an approved protocol that outlines objectives, methods, and data collection procedures. These operational standards form the backbone of GLP implementation, ensuring that studies follow a reproducible and auditable process.
Extensive documentation and evidence are required to demonstrate adherence to GLP. Laboratories must maintain written standard operating procedures (SOPs), raw data records, calibration logs, and validation reports. Every change or deviation must be documented and justified to preserve data integrity.
Testing, validation, and verification protocols are essential for confirming that methods and equipment produce reliable results. Quality assurance units (QAUs) perform routine inspections and audits to verify that studies are conducted in accordance with GLP.
Reporting obligations include preparing comprehensive final reports that summarize study design, raw data, analyses, and conclusions. Laboratories must archive all study materials, including samples and documentation, for regulatory review.
Maintaining GLP compliance requires continuous oversight. Step-by-step procedures such as periodic training, internal audits, risk assessments, and corrective actions help ensure ongoing conformity with the regulatory expectations outlined in 21 CFR Part 58.
To maintain compliance, laboratories must follow step-by-step procedures for audits, training, and equipment management. Ongoing internal reviews by a Quality Assurance Unit (QAU) verify adherence to GLP and help identify potential issues before they become violations, ensuring continuous improvement and regulatory alignment.
Before a new drug ever reaches clinical trials, it goes through a long and meticulous phase of nonclinical testing. That is where Good Laboratory Practice (GLP) under 21 CFR Part 58 becomes essential. GLP gives pharmaceutical researchers a structured way to ensure every toxicology or pharmacology study produces data that is trustworthy and reproducible. It sets clear expectations for how laboratories operate, from maintaining calibrated equipment to documenting every experiment and result.
Regulators rely on this framework when reviewing Investigational New Drug (IND) applications because it guarantees safety findings come from credible, well-controlled research. When companies follow GLP, they build confidence not just with the FDA but also within their own R&D teams. It keeps science clean, processes consistent, and results defensible, which are all essential for bringing new treatments to patients faster and more safely.
Developing a medical device is not just about innovation; it is about proving safety and performance long before the product reaches a patient. GLP provides that assurance in the testing phase, guiding how biocompatibility, toxicity, and performance studies are planned, executed, and recorded.
Under 21 CFR Part 58, every test must be documented, equipment must be validated, and results must be traceable. For medical device manufacturers, this ensures that the data supporting premarket submissions, such as IDE or 510(k) applications, are reliable and verifiable. GLP aligns with ISO 13485 and the FDA Quality System Regulation (QMSR), forming a bridge between laboratory testing and full-scale production of medical devices. It ensures that what is proven in the lab holds true in real-world use. More than a regulatory checkbox, GLP gives medical device companies a quality foundation that protects their reputations and the patients who rely on their products.
CROs live and breathe research for other companies, so their credibility depends entirely on the quality of their data. Following Good Laboratory Practice (GLP) under 21 CFR Part 58 is how they demonstrate that every study, sample, and report meets the highest scientific and regulatory standards. GLP requires CROs to maintain strong laboratory quality systems, ensuring that each study is managed by a qualified study director and independently audited by a Quality Assurance Unit. That level of oversight matters when multiple clients are counting on accurate, compliant data to move projects forward. For CROs, GLP is more than a regulatory obligation; it is a competitive advantage. It demonstrates reliability, builds client trust, and shows that the organization can deliver data that hold up under FDA or sponsor review every time.
GLP regulations focus on the quality and integrity of nonclinical laboratory studies that assess product safety before human testing. In contrast, GMP governs the manufacturing and quality control of products intended for clinical use or market distribution. GLP ensures data reliability in research, while GMP ensures product consistency, safety, and compliance during large-scale production and distribution.
GLP requires that all study personnel be qualified by education, training, and experience to perform assigned tasks. Each laboratory must maintain up-to-date training documentation, including records of job descriptions, responsibilities, and competency assessments. Ongoing training is mandatory to ensure staff remain proficient in study procedures, equipment use, and regulatory updates, supporting consistent, compliant scientific practices.
Frequent FDA findings include inadequate documentation, such as missing raw data or incomplete study records, and poor equipment calibration or maintenance. Other issues often involve insufficient staff training, lack of a functioning QAU, failure to follow approved protocols, and inadequate archiving of study materials. These deficiencies can lead to data integrity concerns and may render study results unreliable for regulatory submission.
A robust quality management system (QMS) provides the structure for maintaining continuous GLP compliance. A reliable QMS solution integrates procedures for documentation, equipment calibration, and deviation management while streamlining internal audits and corrective actions. By ensuring every process is defined, monitored, and reviewed, a digital QMS helps laboratories detect issues early, maintain data integrity, and align operations with evolving regulatory standards.